Manufacturing associate job description
Manufacturing associate job description
Job purpose of Manufacturing associate is responsible for a wide variety of cell-related functions, including producing cells, intermediate product, and manufacturing final product for commercial distribution. Responsible for following SOPs, performing daily tasks in a clean-room per the current QSRs, retaining records and writing reports. May also be responsible for troubleshooting.
Key duties/responsibilities of Manufacturing associate:
1. Clean and sterilize processing equipment using automated or manual systems
2. Complete successful gowning qualification and flow procedures for clean rooms.
3. Responsible for various duties that are required to produce product including but not limited to cell expansion; cell feeding, harvesting, counting and freezing; product seeding; growth system maintenance; labeling, packaging and freezing of product; and culture media preparation.
4. Responsible for completing paperwork for each task, cleaning procedures, aseptic processing techniques, Good Manufacturing Practices (GMP) and laboratory safety practices and procedures.
5. Read and follow equipment diagrams used in biotech manufacturing
6. Perform operations in the Delta-V process control system
7. Follow procedures needed to support CGMP activities
8. Perform pH and conductivity measurements and filter integrity testing
9. Accurately follow SOP’s for operating production equipment and performing processing steps
10. Follow specific techniques and operations while demonstrating an understanding of cGMPs and how they apply to specific responsibilities
11. Assist in execution of procedures for cell culture manufacturing, purification, or support area of manufacturing using SOP’s and batch records
12. Use equipment and techniques related to support, mammalian cell culture and/or harvest and purification
13. Performs production related tasks as assigned by the Area Supervisor or Group Lead.
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This entry was posted on Monday, March 29th, 2010 at 3:03 am and is filed under Production job description. You can leave a response, or trackback from your own site.
